Lock a subject's data at the question, form, or visit level
You can now lock a subject's questions, forms, or visits to prevent users from modifying that subject's data.
By locking a subject's data at the question, form, or visit level, other users cannot insert new or update existing data for that subject, such as API loaded data or changing the subject number. Subjects can be locked at the form or visit level even if the visit or form is incomplete or has open queries.
Before working with this feature
Sponsor users assigned the Lock Subject Data Entered at a Site permission can now lock a subject's forms or visits to prevent new data from being added or updated by another user. Any user assigned this permission also has the ability to unlock a subject's data.
Any user assigned the View Form Data for Subjects permission will be able to see whether the subject, visit, form, and question are locked as long as they have permissions to view those elements.
Details for sponsor users
- When a subject is locked, all existing data becomes read-only.
- A Locked icon (
) appears next to a subject to indicate it is locked.
- Locking data at the form or visit level also locks any questions that are hidden to the user.
- The options to sign, freeze, unfreeze and verify are still available on locked questions, forms, and visits.
- Normal ranges on lab forms can still be updated even if the lab form is locked.
- Coding continues to run on locked data.
- The Subject Data Extract, Subject Data report, and Subject Queries report reflect the study's design at the time the report is run, even for locked questions.
More information and step-by-step instructions on subject data locking will be available in the Sponsor and CRO User Guide.
Details for site users
- A Locked icon () is visible next to a locked question for a subject with open queries.
- An Unlocked icon (
) appears next to an unlocked question, indicating that the question has been unlocked by a sponsor user.
Impact to integrations
- When a subject's data is locked, site or sponsor users cannot enter new or modify existing Verbatim terms, Indication, and Route.
- Coding activities in Oracle Central Coding are still allowed even if the verbatim, context items, or coding target fields are locked.
- Updates to the coding are reflected in the audit trail.
- Queries cannot be raised, answered, or closed on locked coding items.
Note:
Data for locked questions, forms, and visits cannot be transmitted through integrations into or out of Oracle Clinical One Platform.Impact to rules
- A custom rule will not re-run after its variables or targets are unlocked unless one or more of the questions entered as variables are updated. If a rule needs to be re-run, you must manually select the option to re-run from the Rule's menu.
- A custom rule cannot open queries or apply calculations to locked questions, forms and visits.
- A new notification called Rule Failure Notification for Locked Data is available. Users assigned the Receive Rule Failure Notification for Locked Data permission will receive this notification informing them that some targets were not updated due to them being locked.
Already working in a live study?
Once the upgrade for this release is complete, users will have the ability to perform subject data locking at the question, form and visit level, and view locked and unlocked data. More information on locking subject data will be featured in the Sponsor and CRO User Guide.